SIROLIMUS Recall D-0504-2024
Description: Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
SIROLIMUS Recall D-0504-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0504-2024 |
| Event ID | 94535 |
| Brand | SIROLIMUS |
| Generic Name | SIROLIMUS |
| Manufacturer | SIROLIMUS |
| Original Package? | 1 |
| Active Substance | SIROLIMUS |
| Drug Route | ORAL |
| Distribution | US Nationwide. |
| Quantity | 1,176 bottles |
| Recall Reason | Failed Impurities/Degradation Specifications |
| Drug Classification | Class III |
| Drug Code Info | 20240529 |
| Product NDC | 55111-653 55111-654 |
| Product NUI | N0000175550 N0000175625 N0000175624 |
| Drug UPC | 0355111654018 |
| Pharma Class (PE) | Decreased Immunologic Activity [PE] |
| Pharma Class (EPC) | mTOR Inhibitor Immunosuppressant [EPC] |
| Recall Initiation Date | 20240501 |
| Report Date | 20240529 |
| Classification Date | 20240521 |
| Address | 107 College Rd E Princeton, NJ 08540-6623 United States |
| Recalling Firm | Dr. Reddy's Laboratories, Inc. |
| Unique Ingredient Identifier | W36ZG6FT64 |
| Drug Application Number | ANDA201578 |
| Structured Product Labeling (SPL ID) | f9a9d4b5-1c61-a2e6-5511-84b3f4f9b24b |
| Structured Product Labeling (SPL Set ID) | 2e6130e5-fa94-dcf8-605c-817bf396e93d |
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